MAUDE Adverse Event Report: MICROVENTION, INC. TRAXCESS-14; WIRE, GUIDE, CATHETER

Model Number	GW1420040
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the distributor: 1 unit without product identification in different language.No patient involvement.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.Imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation found the traxcess 14 guidewire box was returned without a 27 languages label, which is consistent with the customer provided images and the alleged product issue.
Event or Problem Description
As reported by the distributor: 1 unit without product identification in different language.No patient involvement.

• Brand Name: TRAXCESS-14
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21095357
• Report Number: 2032493-2025-00034
• Device Sequence Number: 8629448
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)240820(17)270731(10)240820
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K080863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: GW1420040
• Device Lot Number: 240820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown